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Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System.

Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm based on collaborative robotics technology, providing guidance for the positioning and orientation of a Transcranial Magnetic Stimulation (TMS) coil - connected to its stimulator - under the supervision of an optical tracking system. Axilum Robotics TMS-Cobot TS MV comprises the electromechanical collaborative arm on its cart, its optical tracking system, with its software, 3D camera and a coil adaption kits with its mechanical adaptor, to fix the coil on the robotic arm, as well as a contact sensor. The device is intended to be used in combination with the TMS stimulator, treatment coil and treatment chair from the previously-cleared MagVenture MagVita system.

The provided text describes the acceptance criteria and the study performed for the Axilum Robotics TMS-Cobot TS MV device. However, it does not include details regarding a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide specific quantitative results for accuracy, repeatability, or a breakdown of the ground truth establishment process for the test set in the way a typical AI/ML medical device submission might.

The document indicates that the device is a computer-controlled electromechanical arm that assists in positioning a TMS coil, suggesting its role is primarily mechanical assistance rather than an AI/ML algorithm performing independent diagnostic or treatment decisions. Therefore, the "study that proves the device meets the acceptance criteria" focuses on functional performance, safety, and compatibility with a predicate device, rather than the kind of AI/ML performance metrics (e.g., sensitivity, specificity, AUC) typically evaluated for diagnostic AI systems.

Based on the provided text, here's an attempt to extract the information you requested, noting where information is not explicitly available in the document:

Acceptance Criteria and Device Performance for Axilum Robotics TMS-Cobot TS MV

The Axilum Robotics TMS-Cobot TS MV is an electromechanical arm designed to assist in the spatial positioning and orientation of a Transcranial Magnetic Stimulation (TMS) coil. The performance evaluation focuses on safety, functional operation, and compatibility as an accessory to an existing TMS system (MagVita TMS Therapy System).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size (e.g., number of subjects, cases, or specific test runs) used for the functional and compatibility tests. It reports that "nonclinical testing" was completed, which typically refers to lab-based testing rather than clinical trials with human subjects for this type of accessory device.

• Test Set Sample Size: Not explicitly stated in the provided text.
• Data Provenance: The testing appears to be nonclinical (lab-based) as opposed to a clinical study with patient data. Therefore, details like country of origin or retrospective/prospective nature are not applicable in the context of patient data, but rather pertain to the testing environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of information (experts establishing ground truth) is typically relevant for AI/ML diagnostic devices where human expert annotations or diagnoses serve as reference standards. For this device, which is an electromechanical arm for positioning, "ground truth" would relate to precise mechanical measurements and functional performance rather than clinical diagnoses.

• Experts: Not explicitly stated or applicable in the traditional sense of clinical ground truth establishment for a diagnostic device. The performance validation relies on engineering measurements and functional verification against specifications and safety standards.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

As the "test set" pertains to nonclinical functional and safety testing of an electromechanical device, an "adjudication method" in the clinical imaging sense (e.g., 2+1, 3+1 consensus) is not applicable. Performance is likely adjudicated by meeting predefined engineering specifications and safety thresholds.

• Adjudication Method: Not applicable in the context of clinical ground truth. Performance is presumably evaluated against documented engineering specifications and regulatory standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. The provided text does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. This type of study is more common for AI systems that aid in image interpretation or diagnosis. The TMS-Cobot TS MV is a robotic positioning device.

• MRMC Study: No, not mentioned.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is an electromechanical arm that is "computer controlled" and provides "guidance for the positioning and orientation" of a TMS coil "under the supervision of an optical tracking system." It also mentions "Robot-automated" head motion compensation and a "Human pilot through the free-drive mode." This indicates it's an accessory that operates in conjunction with a human operator and other system components (MagVita TMS Therapy System). It is not a standalone AI algorithm providing a diagnostic output without human intervention.

• Standalone Performance: The device is presented as an accessory with human supervision and interaction; therefore, a pure "algorithm only" standalone performance evaluation in the context of diagnostics is not applicable. Its performance is integrated with the larger MagVita TMS Therapy System and human oversight.

7. The Type of Ground Truth Used

The "ground truth" is based on established engineering principles, safety standards, and functional specifications for robotic and medical devices. This includes:

• Engineering Specifications: For accuracy, repeatability, range of motion, collision detection, and performance of free-drive mode.
• Safety Standards: Compliance with AAMI, IEC, and EN standards for electrical safety, electromagnetic compatibility, and software validation.
• Usability Standards: Compliance with IEC 62366 and FDA guidance for human factors.
• Compatibility Verification: Ensuring safe and effective operation with the MagVita TMS Therapy System components.

It is not based on expert clinical consensus (e.g., for diagnosis), pathology, or direct patient outcomes data in the way a diagnostic AI would be evaluated.

8. The Sample Size for the Training Set

This device is an electromechanical robot. The concept of a "training set" typically applies to machine learning algorithms where data is used to train a model. While the device utilizes "computer controlled" and "collaborative robotics technology," it's not explicitly described as an adaptive AI/ML system that undergoes a data-driven training phase in the traditional sense for medical imaging AI. Its "training" would be more akin to software development, calibration, and engineering design.

• Training Set Sample Size: Not applicable or not specified in the context of a machine learning training dataset.

9. How the Ground Truth for the Training Set Was Established

As the concept of a training set for an AI/ML model is not explicitly defined for this device, the establishment of "ground truth" for it is not applicable in the way it would be for a data-driven AI. Instead, the design and validation are based on engineering specifications, physical models, and control algorithms.

• Ground Truth for Training Set: Not applicable in the context of a typical AI/ML training dataset.

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